immunization with gp100 protein vaccine in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: vaccines may make the body build an immune response to kill tumor cells. purpose: this randomized phase ii trial is studying immunization using two different gp100 protein vaccines to compare how well they work in treating patients with metastatic melanoma.

objectives: primary * compare the clinical response in patients with metastatic melanoma immunized with recombinant gp100 protein (184v) emulsified in montanide isa-51 with or without gp100:209-217 (210m) peptide. secondary * compare the toxicity profile of these immunizations in these patients. outline: this is a randomized study. patients are assigned to 1 of 2 cohorts according to hla-a2\*0201 status. patients assigned to cohort 1 are then randomized to 1 of 2 treatment arms. * cohort 1 (hla-a2\*0201-positive patients): patients are randomized to 1 of 2 treatment arms. * arm i: patients receive immunization comprising recombinant gp100 protein (184v) emulsified in montanide isa-51 subcutaneously (sc) on days 1, 22, 43, and 64 (1 course). * arm ii: patients receive immunization comprising recombinant gp100 protein (184v) and gp100:209-217 (210m) peptide emulsified in montanide isa-51 sc on days 1, 22, 43, and 64 (1 course). * cohort 2 (hla-a2\*0201-negative patients): patients receive immunization as in cohort 1, arm i. in both cohorts, treatment continues in the absence of rapid disease progression or unacceptable toxicity. in both cohorts, patients are evaluated 3-4 weeks after the fourth immunization. patients achieving stable disease or a partial response receive retreatment according to their assigned cohort. patients with progressive disease who are eligible for interleukin-2 (il-2) receive retreatment according to their assigned cohort and high-dose il-2 iv over 15 minutes 3 times daily on days 2-5, 23-26, 44-47, and 65-68 (1 course). patients receive up to 3 retreatment courses. patients achieving a complete response (cr) receive 1 retreatment course beyond cr. patients with progressive disease who are ineligible for il-2 administration are removed from the study. projected accrual: a total of 45-75 patients (30-50 for cohort 1 \[15-25 per treatment arm\] and 15-25 for cohort 2) will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: * diagnosis of metastatic melanoma * measurable disease * progressive disease during or after prior standard treatment with or without interleukin-2 patient characteristics: age * 16 and over performance status * ecog 0-2 life expectancy * more than 6 months hematopoietic * wbc at least 3,000/mm\^3 * platelet count at least 90,000/mm\^3 * lymphocyte count greater than 500/mm\^3 hepatic * bilirubin no greater than 2.0 mg/dl (less than 3.0 mg/dl for patients with gilbert's syndrome) * alt and ast less than 3 times normal * hepatitis b surface antigen negative renal * creatinine no greater than 2.0 mg/dl cardiovascular * no symptomatic cardiac disease immunologic * no active systemic infection * no autoimmune disease * no known immunodeficiency disease * no known hypersensitivity to study agents * no form of primary or secondary immunodeficiency * no opportunistic infection * hiv negative other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * see disease characteristics * no prior gp100 peptide vaccine chemotherapy * more than 6 weeks since prior nitrosoureas endocrine therapy * no concurrent systemic steroid therapy radiotherapy * not specified surgery * prior recent (within the past 3 weeks) minor surgical procedures allowed other * recovered from prior therapy (toxicity no greater than grade 1) * more than 3 weeks since prior systemic anticancer therapy * no other concurrent systemic anticancer therapy

Keywords: stage iv melanoma recurrent melanoma